跳至主要内容
临床试验/NCT06548841
NCT06548841已完成不适用

Development and Validation of (Bio)Sensors for the Identification of Pathogens

University of Bologna1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
1
主要终点
The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests

研究概览

简要总结

The recent COVID-19 pandemic has revealed the need to develop tests that are accurate, rapid, and inexpensive for the diagnosis of infectious diseases. This problem is relevant not only for viruses, but also for bacteria and parasites: the identification of pathogens at low concentrations by simple and accurate methods is still largely unsatisfied because these microorganisms are structurally complex and are incorporated in composite and diverse biological samples, which can create relevant interferences in pathogens' detection. Direct diagnostic approaches, such as microscopic examination, culture and molecular testing are carried out in equipped laboratories and require long waiting times to obtain the results. Recently developed point-of-care (POC) tests are a group of technologies that miniaturize tests into portable devices such that they can be performed both in well-equipped laboratories and outside the conventional laboratory setting. The present study aims to explore the feasibility and adaptability of newly developed platforms to detect: 1. a virus (SARS-CoV2), 2. a bacterium (Pseudomonas aeruginosa) and 3. a protozoan parasite (Leishmania infantum) in clinical specimens, such as blood and respiratory samples. These newly developed platforms are expected to overcome the current limitations of molecular testing (high cost, time required and need for well-equipped laboratories) and rapid testing (high number of false-negative results). In addition, the newly developed platforms may have important clinical application in low-income countries, which will benefit from a simple and inexpensive approach to detect the many infectious diseases that affect millions of people each year.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obtaining informed consent
  • •Age ≥ 18 years
  • •Patients who meet one of the following conditions: SARS-CoV2 positive patients (group 1), SARS-CoV2 negative patients (group 2), P. aeruginosa positive patients (group 3), P. aeruginosa negative patients (group 4), L. infantum positive patients (group 5), L. infantum negative patients (group 6).

排除标准

  • 未提供

结局指标

主要结局

The evaluation of the sensitivity and specificity of new nanobiotechnological platforms compared to gold standard diagnostic tests

时间窗: 16 months

The sensitivity and the specificity will be estimated by creating the confusion matrix corresponding to the classification between signals significant (beyond Limit Of Detection, LOD) and samples giving non-significant signals (below LOD). Where the analytical problem is described by other variables than the electrochemiluminescent analytical signal, multivariate classification methods shall be applied. The correlation and interaction between variables will also be estimated.

次要结局

未报告次要终点

研究者

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiziana Lazzarotto

Director of the Microbiology Unit - IRCCS Azienda Ospedaliero-Universitaria di Bologna

University of Bologna

研究点 (1)

Loading locations...

相似试验

Development and Validation of (Bio)Sensors for the... | 临床试验